Testing drives drug development. From laboratory tests on patient specimens comes almost all of the clinical data needed for a new drug application. How and where those specimens are collected, transported, stored, and analyzed impacts the quality and usefulness of the data they produce. In the past, most tests were processed by local, academic, and specialized testing laboratories and coordinated by each investigator. However, centralized testing is becoming an accelerated trend – one that uses advanced technology and global operations to concentrate oncology clinical trial tests in a single, central laboratory.
The core value of a central lab is consistency. When local laboratories perform testing, their results will be different and results vary over the course of the trial. Central laboratory testing, on the other hand, offers ‘combinable data.’ The end product is that a result from a central laboratory is similar regardless of the global location where it originated from and the lab location where it is tested. At all of Covance’s central laboratories — in Indianapolis, Geneva, Singapore, Shanghai, and Tokyo — we generate data from the same analytical method platform, SOPs, equipment, reagents, and standards, eliminating variables that affect tests results. Continue reading
Last month I was interviewed by ClinicalLeader for an article about how the central laboratory approach, as opposed to the traditional, distributed model of clinical trial lab testing, is driving higher quality and efficiency in clinical drug development. The article highlighted Covance Central Laboratory Services (Covance CLS) as an example for the new model emerging – using advanced technologies and global operations to concentrate all clinical trial tests into a single, central laboratory. The article also addressed how and why the industry is beginning to adopt central laboratory services for oncology studies. Continue reading
Cancer is a disease that affects all of us; we all know someone with cancer, or have been diagnosed ourselves. Total cancer deaths worldwide in 2008 were approximately 7.6 million – approximately 13% of all deaths worldwide according to the World Health Organization. Therefore, intuitively, one would think that finding cancer patients to participate in clinical trials would not be an issue. However, that’s not the case.
Given the sheer numbers of those afflicted with cancer, we tend to lose sight of the actual prevalence of the disease at a given time in a community. When spread out over a lifetime, cancer is not as common as we assume. So, when posed with the question of where to find cancer patients for clinical trials, intuitive answers will most likely fail. However, statistics can help shed light on the patient recruitment dilemma. Continue reading